Ocular Therapeutix, Inc. can move ahead with clinical development of its new dexamethasone ocular insert OTX-DED after showing statistically significant improvement in bulbar conjunctival hyperemia. However, the company will need to produce more data on how well the product works at actually improving dry eye symptoms, particularly as little separation appeared between the OTX-DED and vehicle hydrogel insert arms, especially entering a market that is getting crowded.
Ocular’s OTX-DED Succeeds In Dry Eye Where OTX-CSI Failed, But More Data Needed
The Phase II trial showed significant improvement in eye redness in patients with dry eye disease, but additional data are needed on DED symptom improvement.

More from Sensory
The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.
But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.
The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.
The dual agonist of the FP and EP3 receptors has shown efficacy in a Japanese Phase III trial and completed its US Phase II study, which aligns with the Japanese firm’s global expansion strategy for glaucoma products.
More from Therapy Areas
Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.
A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.
The UK giant is forecasting peak sales of $5bn plus